医疗器械CE认证标准清单.doc

德信诚培训网医疗器械CE认证标准清单 MDD指令（93/42/EEC）欧盟协调标准协调标准名称（参考文件）被替代的标准（作废日期）对应中文标准EN 980:2008Symbols for use in the labelling of medical devices医疗器械标签用图形符号EN 980:2003(31/05/2010)EN 1041:2008Information supplied by the manufacturer with medical devices医疗产品生产者提供的信息EN 1041:1998(31/08/2011)EN 1060-1:1995+A2:2009 Non-invasive sphygmomanometers - Part 1: General requirements非侵入式血压计.第1部分:一般要求.修改件A1EN ISO 81060-1:2012 (new)Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)非侵入式血压计.第1部分:非自动量测型的一般要求及测试方法EN 1060-2:1995+A1:2009EN 1060-1:1995+A2:20092015年实施EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems非侵入式血压表.第3部分:电机血压表的补充要求EN 1060-3:1997(31/05/2010)EN ISO 10993-1:2009Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2009)医疗器械的生物学评价第1部分:评价和试验EN ISO 10993-1:2003（21/03/2010）GB/T16886.1-2001,IDT, ISO10993-1997EN ISO 10993-3:2009Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)医疗器械的生物学评价第3部分:遗传毒性,致癌性毒性和生殖毒性试验EN ISO 10993-3:2003（21/03/2010）GB/T16886.3-2008,IDTEN 12470-4:2000+A1:2009Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement临床温度计第4部分：用于连续测量的电子温度计的性能EN 12470-4:2000（21/03/2010）EN ISO 13485:2012 (new)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)医疗设备.质量管理体系.管理要求EN ISO 13485:2003YY/T0287- 2003, IDTEN ISO 14155:2011(new)Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)实验于人体的医疗器械临床研究-有效的临床实践EN ISO 14155-1:2009&EN ISO 14155-2:2009(03/04/2012)EN ISO 14971:2012（new）Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-1)医疗器械风险管理的应用EN ISO 14971:2009YY/T0316- 2008, IDTEN ISO23747:2009 Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in Spontaneously breathing humans(ISO23747:2007)麻醉和呼吸设备.自然呼吸者肺功能评估用呼气峰值流量计EN ISO23747:2007 Note 2.1(2010.03.21)EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)医疗电气设备.基本安全和主要性能的一般要求EN 60601-1:1990+A1:1993+A2:1995+ A13:1996EN 60601-1-1:2001EN 60601-1-4:1996+ A1:1999(01/06/2012)EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007 (Modified)医疗电气设备第1-2部分：对安全性的一般要求电磁兼容性要求和试验EN 60601-1-2:2001and its amendment Note 2.1(01/06/2012)YY0505-2005,IDT, IEC60601-1-2:2001EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability (IEC 60601-1-6:2010)医疗电气设备.第1-6部分：对安全性的一般要求.附属标准:使用性EN 60601-1-6:2007Note 2.1(01/04/2013)EN 60601-1-8:2007 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006)医疗电气设备.第1-8部分：对基本安全和主要性能的一般要求.附属标准:对医疗电器设备及医疗电器系统报警系统的测试和指导的一般要求EN 60601-1-8:2004and its amendment(01/06/2012)EN 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentIEC 60601-1-11:2010医用电气设备 - 第1-11：基本安全和基本性能的通用要求 相关标准：医用电气设备和家庭医疗保健环境中使用的医疗电气系统需求first publicationEN 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2:2009)医疗电气设备第2-2部分对高频外科设备的特殊安全要求EN 60601-2-2:2007Note 2.1(01.04.2012)GB9706.4-1999, IDT, IEC60601-2-2:1991EN 60601-2-24:1998 Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998)医疗电气设备第2-24部分输液泵和控制器的特殊安全要求NONEEN 60601-2-25:1995/ A1:1999Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993/A1:1999)医疗电气设备第2-25部分：对心电图仪安全性的特殊要求NONEGB10793-2000,IDT, IEC60601-2-25:1993EN 60601-2-26:2003 Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:2002)医用电气设备第2-25部分：脑电描记器的特殊安全要求EN 60601-2-26:1994Note 2.1(01.03.2006)GB9706.26-2005, IDTEN 60601-2-27:2006 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005)医疗电气设备第2-27部分：对心电图描记监视设备安全性的特殊要求EN 60601-2-27:1994Note 2.1(01.11.2008)GB9706.25-2005,IDTIEC60601-2-27:1994EN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30:1999)医疗电气设备第2-30部分：对自动循环血压间接监视设备安全性的特殊要求EN 60601-2-30:1995Note 2.1(01.02.2003)YY0667-2008,IDT自动循环无创血压监护设备安全和基本性能EN 60601-2-34:2000 Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment (IEC 60601-2-34:2000) 医疗电气设备第2-34部分：对直接式血压监视设备安全性的特殊要求EN 60601-2-34:1995Note 2.1(01.11.2003)EN 60601-2-37:2008 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007)医疗电气设备第2-37部分.超声医疗诊断和监测设备安全的特殊要求EN 60601-2-37:2001and its amendmentsNote 2.1(01.10.2010)EN 60601-2-40:1998 Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601-2-40:1998)医疗电气设备第2-40部分:电子肌动描记器及诱发反应设备安全性的特殊要求NONEEN 60601-2-47:2001 Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001) 医用电气设备第2-47部分.流动心电图测试系统的特定安全要求(包括基本性能)NONEEN 60601-2-49:2001 Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2001)医疗电气设备第2-49部分.多功能病人监测设备的特殊安全要求NONEYY0668-2008,IDT多参数患者监护设备安全专用要求EN 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (IEC 60601-2-51:2003)医疗电气设备.记录和分析单道和多道心电描记器的特殊安全性要求(包括主要性能)NONEEN 62304:2006 Medical device software - Software life-cycle processes (IEC 62304:2006)医疗设备软件-软件生命周期循环过程NONEYY/T0664- 2008, IDTEN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)医疗设备-医疗设备使用性应用NONE IVD指令（98/79/EC）欧盟协调标准协调标准名称（参考文件）被替代的标准（作废日期）对应中文标准EN 980:2008 Symbols for use in the labelling of medical devices医疗器械标签用图形符号EN 980:2003(31/05/2010)EN ISO 13485:2012 (new)Medical devices - Quality management systems - Requirements for regulatory purposes医疗设备.质量管理体系.管理要求EN ISO 13485:2003YY/T0287- 2003, IDTEN 13612:2002/AC:2002Performance evaluation of in vitro diagnostic medical devices体外诊断设备的性能评估EN ISO 14971:2012（new）Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-1)医疗器械风险管理的应用EN ISO 14971:2009YY/T0316- 2008, IDTEN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)体外诊断医疗器械.制造商提供的信息(标签).术语、定义和一般要求EN ISO 18113-1:2019EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)体外诊断医疗器械 制造商提供的信息(标签) 专业用体外诊断仪器EN ISO 18113-3:2009 EN 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipmentIEC 61010-2-101:2002 (Modified)测量、控制和实验室用电气设备的安全要求.实验室诊断(IVD)医疗设备的特殊要求NONEYY0648-2008,IDTEN 61326-2-6:2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment IEC 61326-2-6:2005测量、控制和实验室用电气设备 电磁兼容性要求 第1部分:一般要求NONEGB/T18268.26-2010, IDTEN 62304:2006 Medical device software - Software life-cycle processes (IEC 62304:2006)医疗器械用软件,软件寿命周期过程NONEYY/T0664- 2008, IDTEN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)医疗设备.医疗设备可用性工程的应用NONE IEC、ISO、ANSI/AAMI等国际标准（已列入欧盟协调标准的除外）IEC、ISO标准名称被替代的标准（作废日期）对应中文标准IEC 61266: 1994 Ultrasonics - Hand-held probe Doppler fetal heartbeat detectors - Performance requirements and methods of measurement and reporting超声学 手持式探头多普勒胎儿心率检测仪 性能要求及测量和报告方法NONEIEC 61157:1992Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment医疗诊断超声设备-声输出的要求NONEGB16846-2008, IDTANSI/AAMI SP-10:2002+A1:2003+A2:2006Manual, electronic, or automatedSphygmomanometers手动，电子或自动血压计NONEYY0670-2008,NEQ,ANSI/AAMI SP-10:2002ISO 80601-2-61：2011(new)Medical electrical equipment Part 2-61:Particular requirements for basic safetyand essential performance of pulseoximeter equip